How the FDA Tests Drugs by Pharmaceutical Companies in the U.S.

The FDA has a five-step process for drug approvals. In this guide, you’ll learn all about this process.

A Pharmaceutical Company’s Role

Before new drugs are submitted for review, a pharmaceutical company must conduct tests in a lab. After the tests are done, the drug company can send an NDA to the FDA. The NDA must include the following:

  • A description of the drug tests
  • The manufacturing information
  • Data from the clinical trials
  • The label for the medication

During the final phase, a group of FDA scientists and physicians will carefully review the research. If they find that the drug has good benefits and minimal risks, it will get approved.

Drug Approval Methods for Generic Drugs

A drug manufacturer will need the FDA’s approval for generic drugs too. However, the approval process is very different. Basically, another clinical trial isn’t required since a generic drug is just a copy of a brand-name drug. The FDA’s application for generic medications is called an ANDA.

Tactics for Over-the-Counter Medications

For over-the-counter drugs, there is an OTC monograph. The monograph is basically a recipe book that contains acceptable formulations and ingredients for over-the-counter drugs. If a drug meets the requirements from the monograph, it can be sold at stores.

In the medical world, there is a process called Medical Legal Regulatory or MLR. An MLR approval ensures that a drug meets the FDA’s standards. If you need MLR approval, the folks at Framework Solutions Inc can help. To learn more, visit

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